Male luer with fluid path and vent path seals

ABSTRACT

A male needleless connector includes a body having a male fitting with a distal port, a valve disposed within the body and having a first position wherein the valve seals the port and a second position wherein the valve does not seal the port, and a sliding seal disposed over a portion of the male fitting and having a first configuration wherein a first portion of the sliding seal is in sealing contact with the male fitting and a second configuration wherein the first portion is not in sealing contact with the male fitting. Moving the sliding seal to the second configuration opens the seal between the sliding seal and the male fitting and displaces the valve to the second position, thereby opening the seal between the valve and the port.

CROSS-REFERENCES TO RELATED APPLICATIONS

Not applicable.

BACKGROUND

1. Field

The present disclosure generally relates to needleless connectors, and,in particular, to self-sealing male needleless connectors.

2. Description of the Related Art

Medical treatments often include the infusion of a medical fluid, forexample a saline solution or a liquid medication, to patients using anintravenous (IV) catheter that is connected though an arrangement offlexible tubing and fittings, commonly referred to as an “IV set,” to asource of fluid, for example an IV bag. Needleless fittings commonlyinclude male and female needleless connectors having a “Luer taper”conforming to an International Standards Organization (ISO) standardwherein mating of Luer fittings forms a liquid-tight connection.

Certain connectors have a self-sealing feature to prevent leakage offluid from the attached tubing when the connector is decoupled from amating connector. Typical self-sealing needleless connectors provideonly a fluid path and, therefore, provide a self-sealing capability onlyfor the fluid path.

SUMMARY

The needleless male connector disclosed herein provides both a fluidpath and a vent path, each having a self-sealing feature whereinconnection of the disclosed male connector to a compatible femaleconnector opens both the fluid and vent paths and disconnection closesboth paths.

In certain embodiments, a male needleless connector is disclosed thatincludes a body having a male fitting with a distal port, a valvedisposed within the body and having a first position wherein the valveseals the port and a second position wherein the valve does not seal theport, and a sliding seal disposed over a portion of the male fitting andhaving a first configuration wherein a first portion of the sliding sealis in sealing contact with the male fitting and a second configurationwherein the first portion is not in sealing contact with the malefitting. Moving the sliding seal to the second configuration opens theseal between the sliding seal and the male fitting and displaces thevalve to the second position, thereby opening the seal between the valveand the port.

In certain embodiments, a needleless connector set is disclosed thatincludes male connector having a body having a male fitting with adistal port, a valve disposed within the body and having a firstposition wherein the valve seals the port and a second position whereinthe valve does not seal the port, and a sliding seal disposed over aportion of the male fitting and having a first configuration wherein afirst portion of the sliding seal is in sealing contact with the malefitting and a second configuration wherein the first portion is not insealing contact with the male fitting. Moving the sliding seal to thesecond configuration opens the seal between the sliding seal and themale fitting and displaces the valve to the second position, therebyopening the seal between the valve and the port. The set also includes afemale connector having a body having a distal surface, an opening onthe distal surface having a first diameter, a first internal passageextending from the opening, and a cavity extending from a proximal endof the first internal passage. The cavity has a second diameter that isgreater than the first diameter. The female connector also has acollapsible valve disposed within the body and having first and secondpositions. The collapsible valve has a distal end with a diameter thatis greater than the first diameter and less than the second diameter, asecond internal passage, and a slit passing from the distal end to thesecond internal passage. The distal end of the collapsible valve isapproximately flush with the distal surface of the body and the slit isclosed when the collapsible valve is in the first position. The distalend of the collapsible valve is disposed within the cavity and the slitis open when the collapsible valve is in the second position. The maleand female connectors are disposed in their respective first positionswhen not mated and disposed in their respective second positions whenmated.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate disclosed embodiments and together with thedescription serve to explain the principles of the disclosedembodiments. In the drawings:

FIGS. 1A-1C are cross-sections of a conventional needleless maleconnector.

FIGS. 2A-2B are cross-sections of an exemplary male needleless connectorand a compatible female connector according to certain aspects of thepresent disclosure.

FIG. 3 is a cross-section depicting the male and female connectors ofFIGS. 2A-2B in an engaged configuration according to certain aspects ofthe present disclosure.

DETAILED DESCRIPTION

The needleless male connector disclosed herein provides both a fluidpath and a vent path, each having a self-sealing feature whereinconnection of the disclosed male connector to a compatible femaleconnector opens both the fluid and vent paths and disconnection closesboth paths.

In the following detailed description, numerous specific details are setforth to provide a full understanding of the present disclosure. It willbe apparent, however, to one ordinarily skilled in the art thatembodiments of the present disclosure may be practiced without some ofthe specific details. In other instances, well-known structures andtechniques have not been shown in detail so as not to obscure thedisclosure. In the referenced drawings, like numbered elements are thesame or essentially similar. Reference numbers may have letter suffixesappended to indicate separate instances of a common element while beingreferred to generically by the same number without a suffix letter.

FIGS. 1A-1C are cross-sections of a conventional needleless maleconnector 4 as disclosed in U.S. Pat. No. 8,182,452. FIG. 1A depicts themale connector 4 and a compatible female connector 2 prior to beingmated. The connector 4 has a male fitting 5 with a port 7 on the tip. Aninternal valve 6 slides relative to the fitting 5 and is biased towardthe proximal direction such that the tip of the valve 6 seals the port 7when the male connector 4 is not mated with female connector 2.

FIGS. 1B and 1C are cross-sections taken on perpendicular planes throughthe mated connectors 2 and 4. In this configuration, the face 3 of thefemale connector 2 has contacted posts 8 that are connected to the valve6 and displaced the posts 8, and therefore the valve 6, in a distaldirection. This motion displaces the tip of valve 6 from the port 7,thereby allowing fluid to flow through the mated connectors 2 and 4along the flow path 9.

It can be seen from the FIGS. 1A-1C that there is no gas flow paththrough the connectors 2 and 4, nor is there a closable vent path to theambient atmosphere of any gas-filled portion of the male connector 4.This is typical of conventional fluid needleless connectors in that theyare generally intended for connecting fluid lines, for example the fluidlines of a medical intravenous (IV) set.

FIGS. 2A-2B are cross-sections of an exemplary male needleless connector100 and a compatible female connector 20 according to certain aspects ofthe present disclosure. The male needleless connector 100 shown in FIG.2A has a body 110 with a male Luer fitting 112 with a port 114 at aproximal end of the fitting 112. In certain embodiments, the malefitting 112 does not have a Luer taper. A valve 120 is slidably disposedwithin the body 110 and partially within the male fitting 112. A sealingtip 140 is disposed over a proximal tip 124 of the valve 120. The valve120 is biased in the proximal direction by the action of an accordionbellows 130 disposed within cavity 104 distal to the valve 120 such thatthe sealing tip 140 sealingly contacts the port 114 of the male fitting112. In this configuration, the external surface 142 of the sealing tip140 is approximately flush with the external surface of the male fitting112 around the port 114. The sealing tip 140 includes a second seal 144that forms a sliding seal between the valve 120 and the male fitting112.

A passage 122 passes through the valve 120 and the sealing tip 140 andcomprises, in this example, a longitudinal fluid passage 122B thatpasses from the open internal cavity 102 of the bellows 130 to a lateralfluid passage 122A that is open to the interior of the male fitting 112.The internal cavity 102 connects to a fluid passage of an attached fluidline or fitting (not shown in FIG. 2A).

The valve 120 has a plurality of fingers 124 that extend toward theproximal end of the valve 120. In this example, there are four fingers124 while, in other embodiments, there may be fewer or greater than fourfingers 124.

A sliding seal 150 is disposed over a portion of the male fitting 112and the fingers 124 with a tip 152 of the sliding seal 150 in sealingcontact with a recess 113 in the male fitting 112. A distal end of thesliding seal 150 is captured, in this example, between two componentsthat form the body 110. The sliding seal 150 also has a shoulder 154disposed proximate to the proximal tips of the fingers 124. In certainembodiments, the sliding seal comprises an elastomeric material. Incertain embodiments, the sliding seal comprises a flexible material.

FIG. 2B illustrates certain features of a compatible female fitting 20that, in this example, is a female Luer fitting that is compatible withthe example male Luer fitting of FIG. 2A. In certain embodiments, theconnector 20 does not have a Luer taper. The connector 20 has a body 30with a distal surface 32 and an opening 34. A collapsible valve 40 isdisposed within the body 30 and has a distal end 42 that, in thisconfiguration, is disposed within the opening 34 such that the distalface 46 is approximately flush with the distal surface 32 of the body30. The tip 42 comprises a slit 44 that is forced closed when the tip 42is positioned as shown in FIG. 2B and will self-open when thecollapsible valve 40 is displaced in a proximal direction such that thetip 42 is displaced into the wider cavity 24 of the body 30. The slit 44passes from the distal face 46 into the internal passage 22 thatconnects to a fluid passage of an attached fluid line or fitting (notshown in FIG. 2B).

FIG. 3 is a cross-section depicting the male and female connectors 100,20 of FIGS. 2A-2B in an engaged configuration according to certainaspects of the present disclosure. The body 30 of the female connector20 has been threaded into the body 110 of the male fitting 112 such thatthe connectors 100, 20 are retained in the engaged configuration. As thebody 30 was threaded into the body 110, the distal surface 32 of thebody 30 came into contact with the shoulder 154 of the sliding seal 150and, as the body 30 advanced into the body 110, displaced the shoulder154 and the adjacent fingers 124 in a distal direction. As the distalend of the sliding seal 150 is captured by the body 110, thedisplacement of the shoulder 154 collapses the sliding seal 150generally as shown, as an example, in FIG. 3. The displacement of theshoulder 154 also draws the tip 152 of the sliding seal 150 away fromthe recess 113, thereby opening a vent path 160 from the cavity 104between the sliding seal 150 and the male fitting 114 into the internalcavity 24, indicated in FIG. 3 by the dashed line labeled “160.”

The distal displacement of the finger 124 causes the entire valve 120 tomove in the distal direction, thereby distally displacing the secondseal 144 within the male fitting 112 and the sealing tip 140 from theport 114. At the same time, the male fitting 112 displaced thecollapsible valve 40 such that the slit 44 self-opened. As the secondseal 144 maintains the seal between the valve 120 and male fitting 112,a fluid path 170 is now provided from the internal cavity 102 throughthe mated connectors 100, 20 to the internal passage 22, as indicated bythe solid line labeled “170.” It can be seen that the fluid path 170 andthe vent path 160 are separated by seals between the male fitting 112and the collapsible valve 40, between the second seal 144 of the sealingtip 140 and the male fitting 112, and between the accordion bellows 130and the valve 120. In certain embodiments, the vent path 160 may openbefore the fluid path 170. In other embodiments, the fluid path 170 mayopen before the vent path 160. In other embodiments, the fluid path 170and the vent path 160 may open at approximately the same time.

In certain embodiments, the sliding seal 150 may form a sealing contactwith the male fitting 112 in locations other than tip 152. In certainembodiments, the recess 113 may be absent and the tip 152 seals againsta smooth external surface of the male fitting 112. In certainembodiments, the male fitting 112 may have external features (notshown), for example ridges running in a distal-proximal direction, thatexpand, as the sliding seal is displaced, a portion of the sliding seal150 that sealingly contacts the fitting 112 when in an undisplacedconfiguration.

In summary, it can be seen that the disclosed embodiments of theneedleless connector provide a fluid path and a vent path that are eachsealed when the male and female connectors are not mated and are openedautomatically as the connectors are mated.

The previous description is provided to enable any person skilled in theart to practice the various aspects described herein. While theforegoing has described what are considered to be the best mode and/orother examples, it is understood that various modifications to theseaspects will be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to other aspects. Thus,the claims are not intended to be limited to the aspects shown herein,but is to be accorded the full scope consistent with the languageclaims, wherein reference to an element in the singular is not intendedto mean “one and only one” unless specifically so stated, but rather“one or more.” Unless specifically stated otherwise, the terms “a set”and “some” refer to one or more. Pronouns in the masculine (e.g., his)include the feminine and neuter gender (e.g., her and its) and viceversa. Headings and subheadings, if any, are used for convenience onlyand do not limit the invention.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations. Aphrase such as an aspect may refer to one or more aspects and viceversa. A phrase such as an “embodiment” does not imply that suchembodiment is essential to the subject technology or that suchembodiment applies to all configurations of the subject technology. Adisclosure relating to an embodiment may apply to all embodiments, orone or more embodiments. A phrase such an embodiment may refer to one ormore embodiments and vice versa.

The term “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs.

The terms “include,” “have,” “with,” and the like are intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

No claim element is to be construed under the provisions of 35 U.S.C.§112, sixth paragraph, unless the element is expressly recited using thephrase “means for” or, in the case of a method claim, the element isrecited using the phrase “step for.”

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims.

What is claimed is:
 1. A male needleless connector comprising: a bodyhaving a male fitting with a distal port; a valve disposed within thebody and having a first position wherein the valve seals the port and asecond position wherein the valve does not seal the port; and a slidingseal disposed over a portion of the male fitting and having a firstconfiguration wherein a first portion of the sliding seal is in sealingcontact with the male fitting and a second configuration wherein thefirst portion is not in sealing contact with the male fitting, whereinmoving the sliding seal to the second configuration opens the sealbetween the sliding seal and the male fitting and displaces the valve tothe second position, thereby opening the seal between the valve and theport.
 2. The male needleless connector of claim 1, wherein the malefitting comprises an external surface having a Luer taper.
 3. The maleneedleless connector of claim 1, wherein the first portion of thesliding seal is proximate to a proximal end of the sliding seal.
 4. Themale needleless connector of claim 3, wherein the sliding seal comprisesa second portion that is fixedly sealed to the body.
 5. The maleneedleless connector of claim 4, wherein the second portion is proximateto a distal end of the sliding seal.
 6. The male needleless connector ofclaim 1, wherein the valve comprises at least one finger disposed withina portion of the sliding seal and external to a portion of the malefitting.
 7. The male needleless connector of claim 6, wherein thesliding seal comprises a shoulder proximate to a proximal end of the atleast one finger, the shoulder configured such that displacement of theshoulder in a distal direction causes the shoulder to contact theproximal end of the at least one finger and, upon further distaldisplacement, displace the valve away from the first position toward thesecond position.
 8. The male needleless connector of claim 1, whereinthe valve comprises a sealing tip disposed within the male fitting, thesealing tip having a first portion configured to seal the port when thevalve is in the first position and a second portion that forms a slidingseal with the male fitting in all positions between the first and secondpositions.
 9. The male needleless connector of claim 8, wherein thevalve comprises a fluid passage passing from a distal end of the valveto an opening disposed between the first and second portions of thesealing tip so as to form a portion of a fluid path when the valve isdisplaced from the first position.
 10. The male needleless connector ofclaim 9, further comprising a bellows disposed within the body anddistal to the valve, the bellows having an internal cavity in fluidcommunication with the fluid passage of the valve.
 11. A needlelessconnector set, comprising: male connector comprising: a body having amale fitting with a distal port; a valve disposed within the body andhaving a first position wherein the valve seals the port and a secondposition wherein the valve does not seal the port; and a sliding sealdisposed over a portion of the male fitting and having a firstconfiguration wherein a first portion of the sliding seal is in sealingcontact with the male fitting and a second configuration wherein thefirst portion is not in sealing contact with the male fitting, whereinmoving the sliding seal to the second configuration opens the sealbetween the sliding seal and the male fitting and displaces the valve tothe second position, thereby opening the seal between the valve and theport; and a female connector comprising: a body having a distal surface,an opening on the distal surface having a first diameter, a firstinternal passage extending from the opening, and a cavity extending froma proximal end of the first internal passage, the cavity having a seconddiameter that is greater than the first diameter; and a collapsiblevalve disposed within the body and having first and second positions,the collapsible valve having a distal end with a diameter that isgreater than the first diameter and less than the second diameter, asecond internal passage, and a slit passing from the distal end to thesecond internal passage, wherein the distal end of the collapsible valveis approximately flush with the distal surface of the body and the slitis closed when the collapsible valve is in the first position, andwherein the distal end of the collapsible valve is disposed within thecavity and the slit is open when the collapsible valve is in the secondposition, wherein the male and female connectors are disposed in theirrespective first positions when not mated and disposed in theirrespective second positions when mated.
 12. The connector set of claim11, wherein the male fitting comprises an external surface having a Luertaper and the first internal passage has a corresponding Luer taper. 13.The connector set of claim 12, wherein the first portion of the slidingseal is proximate to a proximal end of the sliding seal.
 14. Theconnector set of claim 13, wherein the sliding seal comprises a secondportion that is fixedly sealed to the body.
 15. The connector set ofclaim 14, wherein the second portion is proximate to a distal end of thesliding seal.
 16. The connector set of claim 11, wherein the valvecomprises at least one finger disposed within a portion of the slidingseal and external to a portion of the male fitting.
 17. The connectorset of claim 16, wherein the sliding seal comprises a shoulder proximateto a proximal end of the at least one finger, the shoulder configuredsuch that displacement of the shoulder in a distal direction causes theshoulder to contact the proximal end of the at least one finger and,upon further distal displacement, displace the valve away from the firstposition toward the second position.
 18. The connector set of claim 11,wherein the valve comprises a sealing tip disposed within the malefitting, the sealing tip having a first portion configured to seal theport when the valve is in the first position and a second portion thatforms a sliding seal with the male fitting in all positions between thefirst and second positions.
 19. The connector set of claim 18, whereinthe valve comprises a fluid passage passing from a distal end of thevalve to an opening disposed between the first and second portions ofthe sealing tip so as to form a portion of a fluid path when the valveis displaced from the first position.
 20. The connector set of claim 19,further comprising a bellows disposed within the body of the maleconnector and distal to the valve, the bellows having an internal cavityin fluid communication with the fluid passage of the valve.
 21. Aneedleless connector comprising: a body comprising a fluid path and avent path; a valve disposed within the body; and a seal coupled to thebody, wherein the valve and seal respectively block the fluid and ventpaths when the connector is in an unconnected configuration, and whereinthe fluid and vent paths are open when the connector is in a connectedconfiguration.
 22. The needleless connector of claim 21, wherein: thebody comprises a male fitting; the valve is disposed within the malefitting; and the seal is slidingly disposed over a portion of the malefitting.